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GSK Re-submits Avodart sNDA

GlaxoSmithKline has re-submitted its sNDA for Avodart (dutasteride) to the FDA for prostate cancer risk reduction in men at increased risk of developing the disease.

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By: Tim Wright

Editor-in-Chief, Contract Pharma

GlaxoSmithKline has re-submitted its sNDA for Avodart (dutasteride) to the FDA for prostate cancer risk reduction in men at increased risk of developing the disease.

The new submission provides an update to the initial application in 2009. However, according to the company, the withdrawal of the initial application was not related to new findings about safety or efficacy. Also, the updated submission does not change the interpretation of the data previously submitted.

The company will also submit the provision of this update to the European Regulatory authorities as well.

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